Apparatus and method for protecting an operating field

ABSTRACT

An apparatus for protecting an operating field. The apparatus includes a sheet configured to cover a patient’s hair during an operation. A sealing member is provided on or joined to a leading end of the sheet. The sealing member is configured to be applied to a patient’s skin adjacent to an operating field to create a seal between the operating field and the patient’s hair. At least one anchoring member is joined to the sheet adjacent to the leading end of the sheet. The at least one anchoring member is configured to be attached to the patient’s hair adjacent to the operating field to anchor the apparatus to the patient.

RELATED APPLICATION

The present application is a continuation of U.S. Application No.16/884424, filed May 27, 2020, which claims priority from U.S.Provisional Application No. 62/853,979, filed May 29, 2019, the subjectmatter of both of which are incorporated herein by reference in theirentirety.

TECHNICAL FIELD

This disclosure relates to an apparatus and method for protecting anoperating field.

BACKGROUND

Sterile draping for surgeries performed on hair-bearing areas of thescalp can be a challenge for users, such as plastic surgeons, head &neck surgeons, and neurosurgeons. Hair in the surgical field may pose aninfection risk and may also hinder the user’s ability to operate bybecoming entangled in the wound and suture material. One common solutionto hair in the surgical field involves completely shaving the operativearea; indeed, for any surgical procedure elsewhere on the body, hair iscommonly shaved using electric clippers at the beginning of the case.However, shaving the scalp is quite noticeable, especially for patientswith longer hair, and can have negative psychosocial consequences formany patients. It can be particularly undesirable for female patientsundergoing elective cosmetic surgery, such as a face lift, or forchildren undergoing procedures on the scalp.

As such, users generally proceed with scalp or facial surgery by shavingwhat they perceive to be a minimal amount of hair necessary to make anincision, and using various techniques to keep unshaved, longer hair outof the sterile surgical field. Some of these techniques include bundlingand/or braiding the unshaved hair and securing the bundled or braidedhair with a band or clamp. Each these techniques may be inexpensive,readily available, and may decrease procedure time at the end of thecase by minimizing postoperative washing and combing of the patient’shair. However, these techniques consume time at the beginning of aprocedure while the patient is under anesthesia, which for cosmeticprocedures is billable to the patient by the minute. Moreover, manyusers simply do not have the desire or ability to braid or bundle hair.

Another technique to keep unshaved, longer hair out of the sterilesurgical field is to staple surgical drapes to the patient in place atthe operating field. This technique is quick, cheap, and readilyaccessible. However, this technique requires many staples in thepatient’s scalp that must later be removed and may leave small scars.Another technique is to completely wrap the head of a patient with adrape and secure the patient’s hair beneath the drape. This technique isonly useful, though, for procedures involving the forehead or ears andcannot be applied to operating fields within the scalp area.

In spite of hair in the operating field frustrating users, there is verylittle literature devoted to this problem, and the solutions that havebeen proposed are mediocre at best. This is particularly surprising inan age when surgical drapes have become very specialized and expensive.Surgical facilities spend hundreds of dollars on drapes for everycase-all to ensure sterility for the patient and convenience for theuser. Therefore, it may be desirable to provide a drape specialized tokeep unshaved hair out of the operating field.

SUMMARY

In an aspect, an apparatus for helping to protect a patient’s hair isprovided. The apparatus includes a sheet configured to cover a patient’shair during an operation. A sealing member is provided on or joined to aleading end of the sheet. The sealing member is configured to be appliedto a patient’s skin adjacent to an operating field to create a sealbetween the operating field and the patient’s hair. At least oneanchoring member is joined to the sheet adjacent to the leading end ofthe sheet. The at least one anchoring member is configured to beattached to the patient’s hair adjacent to the operating field to anchorthe apparatus to the patient.

In an aspect, a method for helping to protect a patient’s hair isprovided. The method includes providing an apparatus for helping toprotect a patient’s hair. The apparatus is anchored to the patient byattaching at least one anchoring member of the apparatus to thepatient’s hair adjacent to an operating field. A seal is created betweenthe operating field and the patient’s hair by applying a sealing memberof the apparatus to the patient’s skin adjacent to the operating field.The patient’s hair adjacent to the operating field is covered with asheet of the apparatus.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding, reference may be made to the accompanyingdrawings, in which:

FIG. 1 is a bottom view of a specialized drape according to oneconfiguration;

FIG. 2 illustrates the specialized drape of FIG. 1 in a first exampleuse environment;

FIG. 3 illustrates the specialized drape of FIG. 1 in a second exampleuse environment;

FIG. 4 is a top view of the specialized drape of FIG. 1 , in anotherconfiguration;

FIG. 5 illustrates the specialized drape of FIG. 4 in a first exampleuse environment;

FIG. 6 is a bottom view of a portion of the specialized drape of FIG. 1, in another configuration;

FIG. 7 is a bottom view of a portion of the specialized drape of FIG. 6;

FIGS. 8-9 illustrate an example sequence of operation of a portion ofthe specialized drape of FIG. 6 ;

FIG. 10 is a bottom view of the specialized drape of FIG. 1 , in anotherconfiguration;

FIG. 11 is a top view of the specialized drape according to a anotherconfiguration, and in an example use environment;

FIG. 12 is a side view of the specialized drape of FIG. 11 , in theexample use environment; and

FIG. 13 is a perspective top view of the specialized drape of FIG. 11 ,in another configuration, and in an example use environment.

DESCRIPTION OF ASPECTS OF THE DISCLOSURE

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as is commonly understood by one of skill in theart to which the present disclosure pertains.

As used herein, the term “patient” can refer to any warm-bloodedorganism including, but not limited to, human beings, pigs, rats, mice,dogs, goats, sheep, horses, monkeys, apes, rabbits, cattle, farmanimals, livestock, etc.

As used herein, the term “user” can be used interchangeably to refer toan individual who prepares for, assists with, and/or performs aprocedure.

As used herein, the singular forms “a,” “an” and “the” can include theplural forms as well, unless the context clearly indicates otherwise. Itwill be further understood that the terms “comprises” and/or“comprising,” as used herein, can specify the presence of statedfeatures, steps, operations, elements, and/or components, but do notpreclude the presence or addition of one or more other features, steps,operations, elements, components, and/or groups thereof.

As used herein, the term “and/or” can include any and all combinationsof one or more of the associated listed items.

As used herein, phrases such as “between X and Y” can be interpreted toinclude X and Y.

As used herein, the phrase “at least one of X and Y” can be interpretedto include X, Y, or a combination of X and Y. For example, if an elementis described as having at least one of X and Y, the element may, at aparticular time, include X, Y, or a combination of X and Y, theselection of which could vary from time to time. In contrast, the phrase“at least one of X” can be interpreted to include one or more Xs.

It will be understood that when an element is referred to as being “on,”“attached” to, “contacting,” etc., another element, it can be directlyon, attached to or contacting the other element or intervening elementsmay also be present. It will also be appreciated by those of skill inthe art that references to a structure or feature that is disposed“adjacent” another feature may not have portions that overlap orunderlie the adjacent feature.

Spatially relative terms, such as “over” and the like, may be usedherein for ease of description to describe one element or feature’srelationship to another element(s) or feature(s) as illustrated in theFigures. It will be understood that the spatially relative terms canencompass different orientations of a device in use or operation, inaddition to the orientation depicted in the Figures. For example, if adevice in the Figures is inverted, elements described as “over” or “ontop of” other elements or features would then be oriented “under” theother elements or features.

It will be understood that, although the terms “first,” “second,” etc.may be used herein to describe various elements, these elements shouldnot be limited by these terms. These terms are only used to distinguishone element from another. Thus, a “first” element discussed below couldalso be termed a “second” element without departing from the teachingsof the present disclosure. The sequence of operations (or steps) is notlimited to the order presented in the claims or Figures unlessspecifically indicated otherwise.

The invention comprises, consists of, or consists essentially of thefollowing features, in any combination.

FIGS. 1-2 depict a first configuration of a specialized drape 100 forhelping to prevent a patient’s hair from entering an operating fieldduring procedures involving the patient’s scalp, forehead, ears, and/orneck. The specialized drape 100 may include a sheet 102, a sealingmember 104, a hair guiding member 106, and at least one anchoring member108 (shown here as anchoring members 108 a, 108 b, 108 c). The sheet 102may be at least partially translucent and/or transparent so, ifoverlying the face, an anesthesiologist, for example, can monitorendotracheal tube placement throughout a procedure. The sheet 102 mayalso be formed from an impervious material that may help to protect thepatient’s hair H and/or skin S outside of the operating field OF fromthe byproducts of surgery (FIG. 2 ). The sheet 102 may be sterile ornon-sterile, depending on the procedure.

The sealing member 104 may be incorporated within, provided on, and/orattached to the sheet 102 at or adjacent to a leading end 110 of thesheet 102. The sealing member 104 is configured to help separate theoperating field OF from the patient’s hair H and/or skin S outside ofthe operating field OF (FIG. 2 ). The sealing member 104 may be anadhesive, glue, resilient strip (e.g., silicone), or any other desiredbarrier that can be configured to separate the operating field OF fromthe patient’s hair. In the example configuration shown in FIG. 1 , thesealing member is an adhesive provided on the leading end 110 of thesheet 102. A removable protective strip (not shown) may cover theadhesive sealing member 104 prior to use. The sealing member 104 may bea hydrocolloid adhesive. The hydrocolloid adhesive may allow for bettercontact and seal around concave and circular surfaces that may containsmall stumps of residual hair after shaving with electric clippers thanregular tape adhesives. Moreover, the hydrocolloid adhesive may beeasier to remove and less likely to cause an adverse skin reaction inpatients with sensitive skin than would regular tape adhesives.

Although the sealing member 104 has been described as being provided onthe leading end 110 of the sheet 102, it is contemplated that thesealing member 104, such as a glue-based sealing member 104, may befirst provided on the patient’s skin S instead of on the leading end 110of the sheet 102. Once provided on the patient’s skin, the leading end110 of the sheet 102 may be pressed onto the sealing member 104 to jointhe sealing member 104 to the leading end 110 of the sheet 104 and thesheet 104 to the patient.

The hair guiding member 106 is incorporated within, provided on, and/orattached to the sheet 102 adjacent to the leading end 110 of the sheet102. The hair guiding member 106 may be configured to comb and hold thepatient’s hair H out of an operating field OF during application of thespecialized drape 100 (FIG. 2 ). The hair guiding member 106 may be atleast partially formed from a hook portion and/or a loop portion of ahook-and-loop fastener.

The at least one anchoring member 108 is incorporated within, providedon, and/or attached to the sheet 102 adjacent to the leading end 110 ofthe sheet 102. The at least one anchoring member 108 may be configuredto be attached to the patient’s hair H during application of thespecialized drape 100. The at least one anchoring member 108, onceattached to the patient’s hair H, may anchor the specialized drape 100to the patient and help avoid displacement of the specialized drape 100during a procedure (FIG. 2 ). The at least one anchoring member 108 maybe a hair clip, a comb, a hairpin, any other fastener suitable forattaching the specialized drape 100 to the patient, or any combinationthereof. In the example configuration shown in FIGS. 1-2 , thespecialized drape 100 includes a plurality of hair clip anchoringmembers 108 (shown here as hair clip anchoring members 108 a, 108 b, 108c).

In its packaging, the sheet 102 may be folded on top of the at least oneanchoring member 108, and the sealing member 104 may be covered andprotected by the removable protective strip. To apply the specializeddrape 100 to a patient, a user gently but firmly combs the patient’shair away from an operating field OF with the hair guiding member 106.The at least one anchoring member 108 may be attached to the patient’shair H while and/or after the hair guiding member 106 is used to combthe patient’s hair H away from the operating field OF. For example, theat least one anchoring member 108 may be inserted into the patient’shair H and then “snapped” into locking engagement with the patient’shair H through the use of a snap-attachment mechanism of the anchoringmember 108.

Once the specialized drape 100 has been secured/anchored to thepatient’s hair H through the hair guiding member 106 and/or the at leastone anchoring member 108, the user removes the protective strip andpresses the sealing member 104 onto a shaved area at an edge E of theoperating field OF. As shown in FIG. 2 , the user then unfolds the sheet102 over the patient’s hair H. At this point, all hair H adjacent to theoperating field OF should be covered by the specialized drape 100 and anappropriate seal has been created along the edges E of the operatingfield OF. The operating field OF may now be prepped and disinfectedwith, for example, betadine or chlorhexidine, and may be draped withstandard sterile adhesive drapes according to usual sterile techniques.Alternatively, the specialized drape 100 may be packaged sterilely andthe user may apply the specialized drape 100 as described above and in asterile fashion once the designated operating field OF has been shavedand disinfected. At the end of surgery, the specialized drape 100 isremoved and may be discarded or cleaned and sterilized using knowntechniques.

The sequence of applying the specialized drape 100 to a patientpresented above illustrates just one example sequence of operation. Thissequence is not intended to limit the manner in which the specializeddrape 100 is applied to a patient. Any of the steps detailed above canbe performed before or after any other step depending on theconfiguration of the of the specialized drape 100 and/or the procedure.For example, when the specialized drape 100 includes a glue-basedsealing member 104, it may be desirable to apply the glue-based sealingmember 104 to the patient’s skin S before attaching the rest of thespecialized drape 100 in the manner described above.

The specialized drape 100 may have alternate configurations in order tocustomize the specialized drape 100 for different procedures. Forexample, particular configurations of the specialized drape 100 may havemore of or less of any of the features discussed above. Further,particular configurations of the specialized drape 100 may requiredifferent sizes for each of the features discussed above based onincision requirements for different surgical procedures.

FIGS. 1-15 depict example alternative configurations for the specializeddrape. The configuration shown in FIGS. 1-2 is a substantially linearconfiguration of the specialized drape 100 that may be particularly wellsuited for large scalp wounds, such as bicoronal incisions. FIG. 3 showsthe use of two linear specialized drapes 100 (shown here as specializeddrapes 100 a and 100 b) on a patient’s scalp.

The configuration shown in FIG. 4 is a specialized drape 512 that has asubstantially U-shaped configuration. The U-shaped specialized drape 512may be flexible and versatile so that a user may use the U-shapedspecialized drape 512 as a linear specialized drape, and additionallymay use the U-shaped specialized drape as a substantially circulardrape. As shown in FIG. 4 , the U-shaped specialized drape 512 includesa plurality of hair clip anchoring members 108 (shown here as hair clipanchoring members 108 a, 108 b, 108 c, 108 d). Although not shown inFIG. 4 , the U-shaped specialized drape 512 may include a hair guidingmember 106. FIG. 5 depicts the U-shaped specialized drape 512 beingselectively flexed and used as a substantially circular drape. TheU-shaped specialized drape 512, when maneuvered into a substantiallycircular shape, may be particularly well suited for being placed aroundthe circumference of a small incision and/or a small operating field OFfor excision of a 1-2 cm lesion of the scalp.

The configuration shown in FIGS. 6-7 is a specialized drape 814 that hasa substantially circular configuration. The sheet 102 of the circularspecialized drape 814 may include a circular opening 816 that isconfigured to be placed over an operating field OF. The circular openingmay be covered by an incise drape 818. The incise drape 818 may have anadhesive provided thereon so that the incise drape 818 may function asthe sealing member 104 when in use. Further, the incise drape 818 mayhave antimicrobial properties to help keep the operating field sterile.As shown in FIG. 7 , a removable protective sheet 920 may cover theadhesive provided on the incise drape 818 prior to use of the circularspecialized drape 814. FIG. 8 depicts the circular specialized drape 814in use with the incise drape 818 provided over an operating field OF. Asshown in FIG. 9 , once the circular specialized drape 814 is inposition, a user may cut through a portion of the incise drape 818 toaccess the operating field OF.

The incise drape 818 may also be utilized with the linear specializeddrape 100. For example, as shown in FIG. 10 , the incise drape 818 mayextend between two linear specialized drapes 100 (shown here as linearspecialized drapes 100 a and 100 b). In this configuration, the incisedrape 818 may be provided over an operating field OF that is positionedbetween the two linear specialized drapes 100 a, 100 b. Further in theconfiguration shown in FIG. 10 , the incise drape 818 may function as asealing member 104.

FIGS. 11-13 depict another configuration of a specialized drape 1322.Similar to the linear specialized drape shown in FIG. 1 , thespecialized drape 1322 of FIGS. 11-13 includes a sheet 102, a sealingmember 104, and at least one anchoring member 1322. However, unlike thehair-clip anchoring members 108 a, 108 b, 108 c of the linearspecialized drape 100 shown in FIG. 1 , the anchoring member 1324 of thespecialized drape 1322 of FIGS. 11-13 is configured as a comb. The combanchoring member 1324 has a flexible design that can contour to thepatient’s head P (FIGS. 11-12 ) or around circular operating fields OF(FIG. 13 ). Teeth 1326 of the comb anchoring member 1324 allow the combanchoring member 1324 to maintain a firm hold in the patient’s hair H.The comb anchoring member 1324 may be configured to comb and hold thepatient’s hair H out of the operating field OF during application of thespecialized drape 1322, and thus may function in place of the hairguiding member 106 described above.

In its packaging, the sheet 102 may be folded on top of the combanchoring member 1324. Further, in its packaging, the sealing member 104may be protected by the removable protective strip (not shown). To applythe specialized drape 1322 of FIGS. 11-13 , a user gently but firmlyinserts the comb anchoring member 1324 into the patient’s hair Hadjacent to an operating field OF. Once the comb anchoring member 1324,and correspondingly the specialized drape 1322, is secured to thepatient’s hair H, the user peels off the protective strip and pressesthe sealing member 104 onto a shaved area at an edge E of the operatingfield OF. The user then unfolds the sheet 102 over the patient’s hair H.At this point, all patient hair adjacent to the operating field shouldbe covered by sheet 102 and an appropriate seal has been created alongthe edges E of the operating field OF (FIGS. 11-13 ). The operatingfield OF may now be prepped and disinfected with, for example, betadineor chlorhexidine, and may be draped with standard sterile adhesivedrapes according to usual sterile techniques. Alternatively, thespecialized drape 1322 may be packaged sterilely and the user may applythe specialized drape 1322 as described above and in a sterile fashiononce the designated operating field OF has been shaved and disinfected.At the end of surgery, the specialized drape 1322 is removed and may bediscarded or cleaned and sterilized using known techniques.

The sequence of applying the specialized drape 1322 to a patientpresented above illustrates just one example sequence of operation. Thissequence is not intended to limit the manner in which the specializeddrape 1322 is applied to a patient. Any of the steps detailed below canbe performed before or after any other step depending on theconfiguration of the of the specialized drape 1322. For example, whenthe specialized drape 1322 includes a glue-based sealing member 104, itmay be desirable to apply the glue-based sealing member 104 to thepatient’s skin S before attaching the rest of the specialized drape 1322in the manner described above.

The specialized drape 1322 of FIGS. 11-13 may have multiple shapes andsizes available that are customizable to different procedures. A longer,larger sheet 102 with a comb anchoring member 1324 having wider teeth1326 may be particularly appropriate for bicoronal incisions that extendfrom one ear to the other over the top of the scalp (FIGS. 11-12 ). Amore rounded comb anchoring member 1324 with shorter teeth 1326 may beparticularly well suited for being placed around the circumference of asmall incision and/or a small operating field OF for excision of a 1-2cm lesion of the scalp (FIG. 13 ). Many combinations of anchoring member1324 and sheet 102 size and shape are possible based on incisionrequirements for different procedures.

While aspects of this disclosure have been particularly shown anddescribed with reference to the example aspects above, it will beunderstood by those of ordinary skill in the art that various additionalaspects may be contemplated. For example, the specific methods describedabove for using the apparatus are merely illustrative; one of ordinaryskill in the art could readily determine any number of tools, sequencesof steps, or other means/options for placing the above-describedapparatus, or components thereof, into positions substantively similarto those shown and described herein. In an effort to maintain clarity inthe Figures, certain ones of duplicative components shown have not beenspecifically numbered, but one of ordinary skill in the art willrealize, based upon the components that were numbered, the elementnumbers which should be associated with the unnumbered components; nodifferentiation between similar components is intended or implied solelyby the presence or absence of an element number in the Figures. Any ofthe described structures and components could be integrally formed as asingle unitary or monolithic piece or made up of separate subcomponents,with either of these formations involving any suitable stock or bespokecomponents and/or any suitable material or combinations of materials;however, the chosen material(s) should be biocompatible for manyapplications. Further, the chosen material(s) may have antimicrobialproperties to help keep an operating field sterile. Any of the describedstructures and components could be disposable or reusable as desired fora particular use environment. Any component could be provided with auser-perceptible marking to indicate a material, configuration, at leastone dimension, or the like pertaining to that component, theuser-perceptible marking potentially aiding a user in selecting onecomponent from an array of similar components for a particular useenvironment. The term “substantially” is used herein to indicate aquality that is largely, but not necessarily wholly, that which isspecified--a “substantial” quality admits of the potential for somerelatively minor inclusion of a non-quality item. Though certaincomponents described herein are shown as having specific geometricshapes, all structures of this disclosure may have any suitable shapes,sizes, configurations, relative relationships, cross-sectional areas, orany other physical characteristics as desirable for a particularapplication. Any structures or features described with reference to oneaspect or configuration could be provided, singly or in combination withother structures or features, to any other aspect or configuration, asit would be impractical to describe each of the aspects andconfigurations discussed herein as having all of the options discussedwith respect to all of the other aspects and configurations. A device ormethod incorporating any of these features should be understood to fallunder the scope of this disclosure as determined based upon the claimsbelow and any equivalents thereof.

Other aspects, objects, and advantages can be obtained from a study ofthe drawings, the disclosure, and the appended claims.

We claim:
 1. An apparatus for helping to protect a patient’s hair,comprising: a sheet configured to cover a patient’s hair during anoperation; a sealing member provided on or joined to a leading end ofthe sheet, the sealing member being configured to be applied to apatient’s skin adjacent to an operating field to create a seal betweenthe operating field and the patient’s hair; and at least one anchoringmember joined to the sheet adjacent to the leading end of the sheet, theat least one anchoring member being configured to be attached to thepatient’s hair adjacent to the operating field to anchor the apparatusto the patient.